<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20211211053349N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-07</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Therapeutic effect of 4% Dimethicone lotion with 4% Eucalyptus sp essential oil on reducing head lice infection.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation and comparison of the therapeutic effect of 4% Dimethicone lotion with 4% Eucalyptus sp essential oil on reducing head lice infection in female primary school students in Kerman.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>192</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65406</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 192 female students with head lice lesions participating in the study are randomly assigned to one of two treatment groups. In this study, the block randomization method, blocks of four, is used. Within each block of 4, 2 people are randomly assigned to group A, and two people to group B. 48 blocks of 4 are used to conduct this study. The software used for block allocation is R software. We randomly select created blocks from numbers 1 to 6. Using R software, we choose a random number between numbers 1 and 6. For example, if number 6 is chosen as the first block and number 2 as the second block, the people who enter the study will be given BAABAABB in order. Finally, group A will receive control intervention and group B will receive treatment intervention. Since the study is complete, the data about intervention in each group can be added to the data frame for analysis. The plotblockrand function is used to generate randomization cards to be used when assigning subjects to treatment. Cards are printed and sealed in envelopes, then when a new subject is registered, the next envelope is opened, and the subject is assigned to the appropriate treatment, Blinding description: This study is double blind, the patient and the treating doctor are not aware of the type of treatment. Dimethicone lotion 4% and eucalyptus essential oil 4% are coded by the pharmacist and then the drug codes are returned after the results are determined.</study_design>
      <phase>3</phase>
      <hc_freetext>Head lice.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group, Dimethicone lotion 4%, the amount of Dimethicone lotion used for each person is 50 ml, the contact time of the lotion with the hair is 8 to 10 hours for Dimethicone lotion, both intervention groups after 1, 7, 14 and 21 days later The use of lotion will be examined in order to check the effect of the drug on reducing and stopping pollution in the school. Intervention 2: Intervention group2: The second intervention group was lotion containing 4% eucalyptus essence, The second intervention procedure is a lotion containing 4% eucalyptus essential oil. The 4% eucalyptus essential oil lotion will be formulated by the pharmacognosy and pharmaceutics groups of the Faculty of Pharmacy in a volume of one liter and will be divided into 50 ml packages, and each package will be placed in opaque containers on both sides. They will be given the label of how to use and the ingredients inside the package. Both intervention groups will be examined after 1, 7, 14 and 21 days after consuming the lotion in order to check the effect of the drug on reducing and stopping pollution in the school.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Data analysis

When:
2023

To whom:
Doctors and researchers working in academic institutions

Conditions:
Only use data analysis

Where to obtain:
Dr Leila Shirani-Bidabadi

How to obtain:
lshiranibidabadi@gmail.com
phone:09132196482

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr leila shirani-Bidabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus Postal code: 7616913555</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>Postal code: 7616913</zip>
        <telephone>+98 34 3132 5700</telephone>
        <email>lshiranibidabadi@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Leila Shirani-Bidabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus    Postal code: 7616913555</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>Postal code: 7616913</zip>
        <telephone>+98 34 3132 5700</telephone>
        <email>lshiranibidabadi@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Female students with head lice
َAged between 6-12 years
Having at least 20 active eggs on visual inspection</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Using hair color, hair gel; Henna, and vegetable oils
Having sensitivity to essential oils
Use of other drugs
People who have already used other treatment methods.
No access to individual</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B85.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pediculosis due to Pediculus humanus capitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group, Dimethicone lotion 4%, the amount of Dimethicone lotion used for each person is 50 ml, the contact time of the lotion with the hair is 8 to 10 hours for Dimethicone lotion, both intervention groups after 1, 7, 14 and 21 days later The use of lotion will be examined in order to check the effect of the drug on reducing and stopping pollution in the school.</i_keyword>
      <i_keyword>Intervention group2: The second intervention group was lotion containing 4% eucalyptus essence, The second intervention procedure is a lotion containing 4% eucalyptus essential oil. The 4% eucalyptus essential oil lotion will be formulated by the pharmacognosy and pharmaceutics groups of the Faculty of Pharmacy in a volume of one liter and will be divided into 50 ml packages, and each package will be placed in opaque containers on both sides. They will be given the label of how to use and the ingredients inside the package. Both intervention groups will be examined after 1, 7, 14 and 21 days after consuming the lotion in order to check the effect of the drug on reducing and stopping pollution in the school.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The percentage of contamination. Timepoint: days1,7,14,28. Method of measurement: Examine.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Drug resistance. Timepoint: Before starting the intervention, 7, 14 and 21 days after using the lotion. Method of measurement: Counting adult lice and their eggs.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-31</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus Postal code: 7616913555 Phone: 034-31325700 Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
